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Atorvastatin Three Year Pediatric Study

17. februar 2021 opdateret af: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Three Year, Prospective, Open-label, Study To Evaluate Clinical Efficacy, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia

The purpose of this study is to characterize three year descriptive growth and development (ie, height, weight, body mass index, Tanner Stage) and efficacy of cholesterol reduction in pediatric subjects with Heterozygous Familial Hypercholesterolemia receiving atorvastatin treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

272

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Bruxelles, Belgien, 1200
        • Cliniques Universitaires Saint-Luc / Pediatrie generale
      • Leuven, Belgien, 3000
        • Universitaire Ziekenhuizen Leuven / Center for Metabolic Diseases
  • Canada
      • Quebec, Canada, G1V 4M6
        • Clinique des maladies lipidiques de Quebec
    • Quebec
      • Sainte-Foy,, Quebec, Canada, G1V 4M6
        • Clinique des Maladies Lipidiques de Quebec Inc
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 119049
        • Moscow State Healthcare Institution 'Morozovskaya Children's City Clinical Hospital'
      • Saint-Petersburg, Den Russiske Føderation, 194100
        • Saint-Petersburg State Pediatric Medical Academy
      • Saint-Petersburg, Den Russiske Føderation, 196084
        • Saint-Petersburg State Healthcare Institution "Children's Polyclinic #35"
      • St Petersburg, Den Russiske Føderation, 194044
        • Autonomous Non-Profit Organization Medical Center 21 Century
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85016
        • Phoenix Children's Hospital
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010
        • Children's National Medical Center
    • Florida
      • Gainesville, Florida, Forenede Stater, 32608
        • University of Florida
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • Medpace Clinical Pharmacology Unit
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • The Children's Hospital of Philadelphia
  • Grækenland
      • Athens, Grækenland, 115 27
        • 1st Pediatrics Clinic , University of Athens, Agia Sofia Hospital
  • Italien
      • Palermo, Italien, 90127
        • Dipartimento di Medicina Clinica e delle Patologie Emergenti-University Hospital of Palermo
      • Roma, Italien, 00161
        • Dipartimento di Clinica e Terapia Medica, Università degli Studi di Roma La Sapienza
  • Kalkun
      • Ankara, Kalkun, 06100
        • Hacettepe University Medical Faculty. Department of Pediatrics. Nutrition and Metabolism Unit
      • Ankara, Kalkun, 6500
        • Gazi University, Medical Faculty
      • Izmir, Kalkun, 35100
        • Ege University Medical Faculty
  • Norge
      • Oslo, Norge, 0027
        • Rikshospitalet Lipidklinikken
  • Polen
      • Bydgoszcz, Polen, 85-667
        • Poradnia Chorob Metabolicznych
      • Warszawa, Polen, 04-730
        • Klinika Chorob Metabolicznych
  • Puerto Rico
      • San German, Puerto Rico, 683
        • Hospital de la Concepcion
  • Schweiz
      • Ch-3010 Bern, Schweiz
        • Dr. med. Jean-Marc Nuoffer
  • Slovakiet
      • Bratislava, Slovakiet, 833 40
        • Metabolicka ambulancia, 2. Detská klinika Lekárskej fakulty Univerzity Komenského
      • Kosice, Slovakiet, 040 01
        • Detska fakultna nemocnica Kosice-old
      • Kosice, Slovakiet, 040 11
        • Detska fakultna nemocnica Kosice
      • Poprad, Slovakiet, 05801
        • Lipmet, s.r.o.
      • Trencin, Slovakiet, 911 71
        • Fakultna nemocnica Trencin
  • Spanien
      • Barcelona, Spanien, 08041
        • Hospital Santa Creu i Sant Pau
      • Esplugues de Llobregat, Spanien, 08950
        • Hospital Sant Joan de Deu
    • Alicante
      • Elche, Alicante, Spanien, 03202
        • Hospital General Universitario de Elche
    • Badajoz
      • Merida, Badajoz, Spanien, 6800
        • Hospital de Mérida
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Hospital Universitario Marqués de Valdecilla
  • Tyskland
      • Berlin, Tyskland, 13353
        • Charité Campus Virchow-Klinikum
      • Freiburg, Tyskland, 79098
        • Augenaerztliche Gemeinschaftspraxis
  • Ungarn
      • Budapest, Ungarn, H-1094
        • Semmelweis Medical University
      • Szekesfehervar, Ungarn, 8003
        • Fejer Megyei Szent Gyorgy Korhaz

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 15 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Heterozygous familial hypercholesterolemia, ages 6-15, LDL greater than 4 mmol/l

Exclusion Criteria:

  • Active liver disease or hepatic dysfunction, or persistent elevations of serum transaminases exceeding three times the upper limit of normal (ULN).

Female of childbearing potential who is not using adequate contraceptive measures or any female who is pregnant or breastfeeding. Any female who becomes pregnant during study participation will be immediately discontinued from treatment and counseled appropriately about the in utero exposure.

Known hypersensitivities to HMG-CoA reductase inhibitors

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Atorvastatin
All subjects will be treated with atorvastatin
Medicin: atorvastatin
Atorvastatin tablets or chewable tablets, 5, 10, 20, 40 mg strengths, once daily, for three years (an 80 mg maximum daily dose is delivered by taking two 40 mg strengths, once daily)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Low Density Lipoprotein Cholesterol (LDL-C; Millimoles Per Liter [mMol/L]) During the Study
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination [ET])
Percent Change From Baseline in LDL-C
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or ET)
High-Density Lipoprotein Cholesterol (HDL-C; mMol/L) During the Study
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in HDL-C
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Total Cholesterol (mMol/L) During the Study
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Total Cholesterol
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Trigylcerides (mMol/L) During the Study
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Trigylcerides
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Very Low-Density Lipoprotein (VLDL; mMol/L) During the Study
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in VLDL
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Apoliprotein A-1 (Apo A-1; Grams Per Liter [g/L]) During the Study
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Apo A-1
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Apoliprotein B (Apo B; g/L) During the Study
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast). Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Apo B
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Assessments were performed in the fasting state (minimum 10-hour fast).
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Number of Participants With Shift From Baseline in Tanner_Stage by Timepoint and Baseline Tanner_Stage
Tidsramme: Baseline, Months 6, 12, 18, 24, 30, and 36/ET
Tanner_Stage was assessed based on 2 components by gender, pubic hair and breasts for females and pubic hair and genitalia for males. If these values of components were not same, then the Tanner_Stage had the higher value of 2 components for each gender by visit.
Baseline, Months 6, 12, 18, 24, 30, and 36/ET
Height (Centimeters [cm]) During the Study: Males
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of height changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Height: Males
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of height changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Height (cm) During the Study: Females
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of height changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Height: Females
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of height changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Weight (Kilograms [kg]) During the Study: Males
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Weight: Males
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of weight changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Weight (kg) During the Study: Females
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of weight changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Weight: Females
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of weight changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Body Mass Index (BMI in kg Per Square Meter [kg/m^2]) During the Study: Males
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in BMI: Males
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of BMI changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
BMI (kg/m^2) During the Study: Females
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of BMI changes during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in BMI: Females
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of BMI changes during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Age (Years) During the Study: Males
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of age during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Age: Males
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of age during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Age (Years) During the Study: Females
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of age during the study. Change from baseline was also determined.
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in Age: Females
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Investigator assessment of age during the study.
Months 1, 2, 3, 6, 12, 18, 24, 30 and 36/ET
Flow-Mediated Dilatation (FMD) During the Study
Tidsramme: Baseline, Months 6, 12, 18, 24, 30 and 36/ET
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100. Change from baseline was also determined.
Baseline, Months 6, 12, 18, 24, 30 and 36/ET
Percent Change From Baseline in FMD
Tidsramme: Months 6, 12, 18, 24, 30 and 36/ET
Percent (%) FMD was calculated as (hyperemic diameter minus resting diameter) divided by the resting diameter multiplied by 100.
Months 6, 12, 18, 24, 30 and 36/ET

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Overall Expected Maturation and Development Consistent With Expectations as Assessed by the Investigator
Tidsramme: Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)
Baseline, Months 1, 2, 3, 6, 12, 18, 24, 30 and 36 (or early termination)
Percentage of Participants by Study Drug Compliance Category
Tidsramme: Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)
Compliance to study drug was categorized as <80%, 80% - 120%, and greater than (>) 120%.
Months 1, 2, 3, 6, 12, 18, 24, 30, and 36 (or early termination)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2009

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

21. januar 2009

Først indsendt, der opfyldte QC-kriterier

22. januar 2009

Først opslået (Skøn)

23. januar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A2581173
  • 2008-006130-95 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Familiær hyperkolesterolæmi

Kliniske forsøg med atorvastatin

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Betingelser

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